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Get Fda 3794 Instructions 2012

The Agency on or after October 1, 2012, unless specifically exempted below; 4) Annual registration fee for a facility producing generic drugs (API, finished dosage form (FDF), or both); and 5) One-time backlog fee. A copy of the completed Form FDA 3794 must be included in the first volume with the cover page (Form 356(h)) of the ANDA, PAS, or DMF submission to the FDA to which it applies. If you need assistance in completing the form, call 301-796-7200 or email: userfees fda.gov. GENERAL INFORM.

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